Drug Interaction With Metformin
Phase 1
Completed
- Conditions
- Healthy Male and Female Subjects
- Interventions
- Registration Number
- NCT00546741
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of the study is to determine the effect of metformin on dapagliflozin exposure and the effect of dapagliflozin on metformin exposure in healthy volunteers. Additionally, the safety and tolerability of dapagliflozin will be assessed in the presence and absence of metformin in healthy volunteers
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria
- Healthy men and women, ages 18-45 with a body mass index of 18-32 kg/m2
Exclusion Criteria
- Unwilling to use acceptable method of birth control
- current or recent (within 1 month) smoker
- abnormal liver function tests
- presence of edema
- history of diabetes mellitus
- history of heart failure or renal insufficiency
- history of chronic or recurrent urinary tract infections, or vulvovaginal mycotic infections
- history of Hepatitis C
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 Dapagliflozin - 2 Metformin - 3 Dapagliflozin + Metformin -
- Primary Outcome Measures
Name Time Method To determine the effect of metformin on the exposure of dapagliflozin and the effect of dapagliflozin on the exposure of metformin in healthy subjects after a single dose of each treatment measures taken daily throughout the study
- Secondary Outcome Measures
Name Time Method To assess the safety and tolerability of dapagliflozin when administered alone or with metformin after a single dose of each treatment measures will be taken at the beginning and end of the study, as well as 1 time every 3 days (Day -1 of each study period)
Trial Locations
- Locations (1)
Bristol-Myers Squibb Clinical Pharmacology Unit
🇺🇸Hamilton, New Jersey, United States